The Effect of Mindfulness-Based Psychoeducation

NCT06417619 | Recruiting DMC

• 1 other identifier: Depression Patients
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized controlled experimental study conducted to determine the effect of mindfulness-based psychoeducation on levels of mindfulness, cognitive defusion, and depression in patients with depression. The sample of the study will consist of 60 patients (30 experimental, 30 control) diagnosed with major depression, recruited from a state hospital. Mindfulness-based psychoeducation will be applied to the experimental group once a week for a total of 8 weeks in the form of group sessions. No intervention other than routine treatment will be applied to the control group. The primary questions that the study aims to answer are as follows: Does mindfulness-based psychoeducation increase levels of mindfulness and cognitive defusion in depression patients? Does mindfulness-based psychoeducation decrease levels of depression in depression patients?

Conditions

Depressive Disorder, Major

Keywords

Depression; Mindfulness; Cognitive Defusion

Outcome Measures

Primary Outcomes (4)

• The Personal Information Data Form baseline and 2 months

  The Personal Information Data Form prepared by the researcher will consist of a total of 10 questions (gender, age, education level, marital status, employment status, income level, cohabitation status, history of hospitalization, history of suicide attempt, medication use, and adherence to treatment).

  2 months

• Beck Depression Inventory baseline and 2 months

  The Beck Depression Inventory, developed by Beck et al. (1961), is designed to measure the risk of depression, level of depressive symptoms, and changes in severity in adults (Beck et al., 1961). The Turkish adaptation of the Beck Depression Inventory was conducted by Hisli (1988). The Beck Depression Scale consists of 21 items, each with four options. Each item scores from 0 to 3. Depression score is obtained by summing these scores. The highest possible score is 63, and a higher total score indicates greater severity of depression. A depression score of 17 or higher indicates depression above normal levels

  2 months

• Mindfulness Scale baseline and 2 months

  The Mindfulness Scale was developed by Brown and Ryan (2003) (Brown \& Ryan, 2003). The Turkish validity and reliability of the scale were conducted by Özyeşil et al. (2011). The scale was designed to measure the overall level of awareness of skills in daily life and attentiveness to them. The scale consists of 15 items, rated on a six-point Likert scale.The scale is also unifactorial, yielding a single score. The lowest possible score on the scale is 15, and the highest is 90. An increase in the score indicates a higher level of mindfulness awareness in individuals.

  2 months

• Drexel Cognitive Defusion Scale baseline and 2 months

  Drexel Cognitive Defusion Scale: The Drexel Cognitive Defusion Scale was developed by Forman et al. (2012) to measure the ability to distance oneself from emotions and thoughts (Forman et al., 2012). The scale consists of 10 items rated on a 6-point Likert scale (0: None; 1: A little, 2: To some extent, 3: Moderate level, 4: Quite a lot, 5: A lot). It is possible to calculate a total score from the scale, where higher scores indicate a higher ability to distance oneself from internal emotions and thoughts.

  2 months

Study Arms (2)

Patients

EXPERIMENTAL

Mindfulness-based psychoeducation will be implemented in the experimental group in the form of group sessions once a week for a total of 8 weeks. Post-tests will be administered immediately after the completion of psychoeducation sessions for the experimental group, and a follow-up test will be conducted 3 months after the post-test.

Behavioral: Mindfulness-Based Psychoeducation

Depression Patients

NO INTERVENTION

No intervention will be applied to the control group other than routine treatment. For the control group, no intervention will be made, and post-tests will be administered 8 weeks after the pre-test, followed by a follow-up test 3 months after the post-test.

Interventions

Mindfulness-Based Psychoeducation BEHAVIORAL

The Effect of Mindfulness-Based Psychoeducation on Depression Level of Depression Patients

Patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those who are literate.
• Those willing to participate in the study voluntarily.
• Those without any communication barriers.
• Those aged between 18 and 65 years.
• Outpatients being followed up with a diagnosis of major depressive disorder according to DSM-5 criteria.
• Those who have not participated in a mindfulness-based psychoeducation program for their illness in the last 5 years.

You may not qualify if:

• Those diagnosed with another comorbid mental illness
• Patients with mental conditions that make cooperation impossible, such as intellectual impairment (mental retardation) or dementia
• Patients with psychotic symptoms in addition to depression illiterate people
• Patients who do not consent to the interview
• Those receiving inpatient treatment

Sponsors & Collaborators

• University of Gaziantep: lead

Study Sites (1)

Gaziantep University

Gaziantep, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Rabia ARPACI, Student

CONTACT

+90542 694 52 31; rabiaarpaci118@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant (Major depression patients)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study is a randomized controlled experimental study (Interventional Study Model)

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: May 16, 2024
• Study Start: January 1, 2024
• Primary Completion: October 30, 2024
• Study Completion: December 30, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

TU (1)